Effectiveness and safety assessment of orthopedic device(LSM-01) for low back pain: a randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial

Cheonan Korean Medicine Hospital of Daejeon University0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年8月30日

试验速览

暂无简介。

•1) 19-70 year old male and female
•2) Subject with lumbar pain above VAS 40mm and those who are taking analgesics for lumbar pain
•3) Subject who voluntarily decides to participate in the study after hearing a sufficient explanation of the purpose of the test and the process and signs the informed consent form

•1) Those who have a history of vertebral fracture or spinal surgery, or have a scheduled surgery within the examination period
•2) Those who have had severe back pain with a VAS of 75mm or more, lasting for 3 days or more within 3 months before participating in the trial
•3) Those with neurological symptoms of sensory and motor paralysis or abnormal findings on L-spine x-ray and CT
•4) Those who have pain in other parts of the body which is more severe than lower back pain
•5) Those who cannot have friction due to skin diseases, inflammation, or wounds around the spine, pelvis, and hip joints
•6) In case of concurrent treatment for back pain other than analgesic medication
•7) Those with serious underlying diseases such as serious cardiovascular disease or tumor
•8) Those with a history of alcohol or drug abuse
•9) Those who cannot write measurement data for subjects by themselves or under the supervision of a guardian/researcher
•10) Those who have participated in other interventional clinical trials within 30 days of trial participation
•11) Any other researcher deemed inappropriate for this test

发起方

Cheonan Korean Medicine Hospital of Daejeon University